Abstract | AIMS/INTRODUCTION: MATERIALS AND METHODS: This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. RESULTS: Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively. CONCLUSIONS:
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Authors | Kazunori Utsunomiya, Naoki Shimmoto, Masayuki Senda, Yuji Kurihara, Ryoji Gunji, Shoko Fujii, Seigo Kakiuchi, Hisataka Fujiwara, Hiroyuki Kameda, Masahiro Tamura, Kohei Kaku |
Journal | Journal of diabetes investigation
(J Diabetes Investig)
Vol. 8
Issue 6
Pg. 766-775
(Nov 2017)
ISSN: 2040-1124 [Electronic] Japan |
PMID | 28107773
(Publication Type: Journal Article, Multicenter Study, Observational Study)
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Copyright | © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd. |
Chemical References |
- Benzhydryl Compounds
- Glucosides
- Hypoglycemic Agents
- Sodium-Glucose Transport Proteins
- 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
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Topics |
- Aged
- Benzhydryl Compounds
(adverse effects, therapeutic use)
- Diabetes Mellitus, Type 2
(drug therapy)
- Female
- Glucosides
(adverse effects, therapeutic use)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Japan
- Male
- Product Surveillance, Postmarketing
- Sodium-Glucose Transport Proteins
(antagonists & inhibitors)
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